Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03232320
Other study ID # MT01-KR16CVD309
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 6, 2017
Est. completion date November 5, 2018

Study information

Verified date March 2019
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date November 5, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Male or female aged 20 to less than 75 years

- Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10

Exclusion Criteria:

- Subjects with pure anterocollis

- Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)

- A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product

- Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Meditoxin
Meditoxin (Botulinum toxin type A)
Placebo
Placebo (Normal saline)

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline week 4 follow-up visit
Secondary Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline week 4 follow-up visit
Secondary Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline week 4 follow-up visit
Secondary Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline week 4 follow-up visit
See also
  Status Clinical Trial Phase
Completed NCT01433757 - Ampicillin for DYT-1 Dystonia Motor Symptoms Phase 1
Recruiting NCT00971854 - Alteration of Deep Brain Stimulation Parameters for Dystonia N/A
Enrolling by invitation NCT00355927 - Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. N/A
Completed NCT00169338 - Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia Phase 2
Completed NCT00004421 - Deep Brain Stimulation in Treating Patients With Dystonia Phase 2/Phase 3
Terminated NCT03270189 - Effect of the Visual Information Change in Functional Dystonia N/A
Recruiting NCT02583074 - Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia N/A
Recruiting NCT06117020 - Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals Phase 1
Completed NCT01432899 - Studying Childhood-Onset Hemidystonia
Completed NCT04948684 - Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
Completed NCT05106816 - The Effects of Vibrotactile Stimulation in Patients With Movement Disorders N/A
Recruiting NCT05027997 - Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm Phase 2
Completed NCT00465790 - Research of Biomarkers in Parkinson Disease Phase 0
Active, not recruiting NCT00142259 - Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia Phase 4
Recruiting NCT05663840 - Effects of Exercise on Dystonia Pathophysiology N/A
Not yet recruiting NCT06038097 - Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia N/A
Recruiting NCT04286308 - Cortical-Basal Ganglia Speech Networks N/A
Active, not recruiting NCT03582891 - The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy N/A
Completed NCT03318120 - Exercise Training in Dystonia N/A
Completed NCT04568681 - Deep Brain Stimulation Effects in Dystonia